Study to Assess EXS21546 in Combination in Patients With Advanced Solid Tumours

NCT05920408 | Terminated Phase 1 DMC

• 1 other identifier: EXS21546-002
• Study Type: interventional
• Target: 6
• Locations: 2 countries
• Sites: 5

Brief Summary

A phase 1B/2A study to assess the safety, tolerability, pharmacokinetic and anti-tumoral activity of EXS21546 in combination with a PD-1 inhibitor in patients with advanced solid tumours.

Conditions

Advanced Solid Tumours

Outcome Measures

Primary Outcomes (5)

• Safety of EXS21546 in combination with nivolumab.

  Incidence of treatment-emergent adverse events (TEAEs) and SAEs characterised by type, incidence, severity (graded by National Cancer Institute \[NCI\] Common Terminology Criteria for Adverse Events \[CTCAE\] v5.0), seriousness, timing and relationship to EXS21546 dosing.

  Through study completion, an average of 6 months

• Dose-limiting toxicities (DLTs) of EXS21546 in combination with nivolumab.

  Incidence of dose limiting toxicities (DLTs) during Cycle 1 (initial 28 days) of treatment with escalating doses of EXS21546 in combination with an approved dose of nivolumab.

  Through dose escalation completion, an average of 6 months

• Preliminary anti-tumoural activity of EXS21546 in combination with nivolumab.

  Objective response rate (ORR) per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.

  Through study completion, an average of 6 months

• Treatment adherence of EXS21546 in combination with nivolumab.

  Number of doses recorded in the treatment diary.

  Through study completion, an average of 6 months

• Tolerability of EXS21546 in combination with nivolumab.

  Frequency of dose interruptions, dose reductions and dose intensity achieved.

  Through study completion, an average of 6 months

Study Arms (1)

EXS21546

EXPERIMENTAL

EXS21546 Granule in Capsule for oral administration

Drug: EXS21546

Interventions

EXS21546 DRUG

EXS21546 Granule in Capsule

EXS21546

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years at time of informed consent.
• Previous histologically confirmed diagnosis of RCC or NSCLC having received previously checkpoint inhibitors as part of a SoC regimen.
• Consent to mandatory paired tumour biopsies of at least one tumour site accessible for repeat biopsies. Planned sites for tumour biopsies must not have been previously irradiated and could be a target lesion of \>2 cm diameter according to RECIST v1.1 and must be approved on a case-by-case basis by the Sponsor.
• Measurable disease as per RECIST v1.1 and documented by computed tomography (CT) and/or magnetic resonance imaging (MRI).

You may not qualify if:

• Any anti-tumour therapy, including investigational therapies, within 4 weeks prior to the first dose of EXS21546.
• Unresolved or unstable serious toxic side-effects of prior chemotherapy or radiotherapy, i.e., ≥ Grade 2 per CTCAE v5.0.
• Concurrent other malignancy that could interfere with response evaluation.
• Symptomatic central nervous system (CNS) malignancy or metastases. Screening of symptomatic participants without history of CNS metastases is not required. Participants with asymptomatic CNS lesions should have completed standard therapy for their CNS lesions 60 days prior to study enrolment.
• History of interstitial lung disease and/or prior immunotherapy-related pneumonitis.
• Patients who have had or are scheduled to have major surgery \< 28 days prior to the first dose of study drug.

Sponsors & Collaborators

• Exscientia AI Limited: lead
• Biotrial: collaborator

Study Sites (5)

Institute Jules Bordet

Brussels, Belgium

Location

CHU Mont-Godinne

Namur, Belgium

Location

Institut Bergonie

Bordeaux, France

Location

Centre GF Leclerc

Dijon, 21000, France

Location

Centre Eugene Marquis

Rennes, France

Location

Study Officials

• Antoine Italiano, MD

  Institut Bergonie, Bordeaux, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2023
• First Posted: June 27, 2023
• Study Start: April 11, 2023
• Primary Completion: September 27, 2023
• Study Completion: October 23, 2023
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2); FR (3)